Multidisciplinary Treatment in Patients With Mild Traumatic Brain Injury

Traumatic Brain Injury With Brief Loss of Consciousness Clinical Trial

Official title:

Effect of Multidisciplinary Treatment in Patients With Mild Traumatic Brain Injury - a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00869154
• Other study ID #: NSD 20425
• Status: Completed
• Phase: N/A
• First received: February 24, 2009
• Last updated: August 11, 2017
• Start date: March 1, 2009
• Est. completion date: March 31, 2015

Study information

• Verified date: August 2017
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to compare a multidisciplinary examination and follow up by rehabilitation program with a multidisciplinary examination, good advice and follow up by the family doctor.

Further on we will examine if there were differing clinical characteristics between patients who attended a planned follow-up session and those that failed to and Prognostic factors in mild traumatic brain injury patients after discharge from hospital.

Description:

2 months after an acute mild traumatic brain injury (TBI) defined as Glasgow Coma Scale between 13 and 15. The patient will get a clinical examination by a specialist in rehabilitation medicine. Patient who wish or need a further follow up, are out of work or school, will be included and randomized to either a multidisciplinary follow up or primary care follow by their family doctor.

Both groups will got a multidisciplinary examination. The multidisciplinary team will work out a rehabilitation program and a report back to their family doctor.

Patient who got a multidisciplinary follow up will then get individual appointments and they will follow an educational program for 4 days. The topics are physical and psychical problems after TBI and problems in daily living and return to work. We will teach a way to accept and deal with their problems. A cognitive behavioural treatment or a psycho educative approach will be central in the treatment. The follow up period will be until 2 years if needed.

For booth groups we will make a registration of sick leave for 5 years. The Extended Glasgow Outcome Scale (GOS- E), Hospital Anxiety and Depression Scale (HAD), Rivermead post concussion symptoms questionnaire and Patient Global Impression of Change (PGIC) after 6 and 12 months.

Department of Economics at the University of Bergen will make cost-benefit analysis.

Further on we will examine if there were differing clinical characteristics between patients who attended a planned follow-up session and those that failed to, if sick leave or return to work could make a difference and Prognostic factors in mild traumatic brain injury patients after discharge from hospital. We also include demographic data, CT findings and clinical data based on information from the medical records, pain drawings and numeric rating scale for pain, Quality of Life and Subjective Health Complaints inventory. We got data about days on sick leave, diagnosis for sick leave and income for the first year before and after the injury from The Norwegian Labour and Welfare Service (NAV) through a third accredited agency Statistics Norway. From Statistics Norway we got additional information about education level and income.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: March 31, 2015
• Est. primary completion date: March 31, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 55 Years

Eligibility

Inclusion Criteria:

• Patient admitted acute to Department of Neurosurgery ICD-10 diagnosed S06.0- S06.9

• Age 16 to 55 years

• Mild traumatic brain injury defined as Glasgow Coma Scale (GCS) between 13 and 15.

Exclusion Criteria:

• Earlier severe traumatic brain injury (GCS 8 or less).

• Serious psychiatric disease (ICD-10 diagnosed last two years).

• Known drug abuse (ICD-10 diagnosed last two years).

• Other serious illness which have a major impact of the outcome.

• Social client last two years as major income

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Traumatic Brain Injury With Brief Loss of Consciousness
• Unconsciousness
• Wounds and Injuries

Intervention

Behavioral:
• primary care follow up
Multidisciplinary examination, good advice from rehabilitation specialists and follow up by the family doctor.
• Multidisciplinary follow up
Multidisciplinary examination and follow up by rehabilitation specialists, a multidisciplinary team following an individual rehabilitation programs.

Locations

Country	Name	City	State
Norway	Haukeland University Hospital, Dept. physical medicine and rehabilitation	Bergen
Norway	Oslo University Hospital, Ullevål	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
Haukeland University Hospital	Stiftelsen Helse og Rehabilitering, Ullevaal University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Return to work	Sick leave for 5 years after injury	6 and 12 months after 1. multidisciplinary examination
Secondary	GOSE	Glasgow Outcome Scale Extended	6 and 12 months after 1. multidisciplinary examination
Secondary	Post-commotio symptoms (RPQ)	The Rivermead Post concussion symptoms Questionnaire	12 months
Secondary	Patient's Global Impression of Change	Patient's Global Impression of Change	12 months

External Links

•   Publications from the project: Multidisciplinary outpatient treatment in patients with mild traumatic brain injury: A randomised controlled intervention study.